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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

Five-Year European Pharmacovigilance Project Comes to an End

A five-year long European research project to improve drug monitoring methods is coming to a close this month.

The project, known as the Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium (PROTECT), is a joint effort by 34 public and private partners and coordinated by the European Medicines Agency (EMA) and GlaxoSmithKline.

About PROTECT

PROTECT was launched in 2009 after receiving funding from the Innovative Medicines Initiative (IMI) and the European Federation of Pharmaceutical Industries and Associations (EFPIA), each of whom contributed approximately €11 million to the project. PROTECT participants include European-based pharmaceutical companies, academic institutions, and regulatory authorities.

The goal of PROTECT is to develop methods to “strengthening the monitoring of the benefit-risk of medicines in Europe.” To achieve its goal, PROTECT has broken up its activities into seven work programs:

WP1: Project management and administration

WP2: Framework for pharmacoepidemiology (PE) studies

WP3: Methods for signal detection

WP4: New methods for data collection from consumers

WP5: Benefit-risk integration and representation

WP6: Replication studies

WP7: Training and Communication

During its five-year run, PROTECT has published a number of documents and tools related to pharmacovigilance, such as an adverse drug reactions database and a web portal dedicated to benefit-risk assessments.

2015 and Beyond

Now that the PROTECT project is ending, EMA will host a symposium on 19 and 20 February 2015 to present the major outcomes of the project. The symposium will be live broadcast on 19 February 2015 from 9:00 am to 6:00 pm GMT and on 20 February 2015 from 8:30 am to 3:00 pm GMT. A video recording will be uploaded to EMA’s website after the event is concluded.

EMA has said the findings “may significantly influence practices in pharmacovigilance and benefit-risk evaluation. The agency plans to conduct a thorough review of PROTECT’s findings in 2015 to “identify priority results [that] have the greatest potential to positively impact public health.”